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Effect of Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening and Enhanced Navigation on Care Delivery for Patients With Breast Cancer (Breast SBDOH)

Primary Purpose

Breast Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring Social and behavioral determinants of health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Based on available EHR data, patients will be eligible for Activities 1 and 2 if they: Are referred to one of the following locations for surgical consult following a new diagnosis of operable (Stage 0-III) breast cancer: the Hospital of the University of Pennsylvania (HUP), Penn Presbyterian Medical Center (PPMC), Pennsylvania Hospital (PAH), and Penn Medicine Radnor Are female Are 18 years of age or older, and Are able to read and speak English or Spanish Clinicians and clinical leaders will be eligible for participation in Activity 2 if they: Presently work as a clinician or clinical leader in breast surgery or oncology Access PennChart as an aspect of their clinical duties Are 18 years of age or older Are able to read and speak English or Spanish Exclusion Criteria: Based on available EHR data, patients will be ineligible if they: Are listed as not wanting to be contacted or solicited for research; Have known metastatic disease at time of enrollment; and/or Do not otherwise meet all of the enrollment criteria Clinicians and clinical leaders will be ineligible for participation in Activity 2 if they: Are not presently engaged in clinical duties or Do not otherwise meet all of the enrollment criteria This study will not exclude men or nonbinary people who may be diagnosed with breast cancer, but investigators anticipate the sample size for these characteristics will be too small to support meaningful analysis.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Other

    Other

    Other

    Other

    Other

    Arm Label

    The Accountable Health Communities Health-Related Social Needs Screening Tool (AHC-HRSN)

    Health Leads Social Screening Tool

    National Comprehensive Care Network (NCCN) Distress Thermometer and Problem List (DT + PL)

    Chatbot

    Interactive Voice Response (IVR) System

    Arm Description

    Patients will be randomized to receive one of three social needs screening instruments. The AHC-HRSN is a 10-item tool developed by the Centers for Medicare and Medicaid Services to assess patient needs in 5 core domains, including housing instability, food insecurity, transportation problems, utility help needs, and interpersonal safety, with eight supplemental domains to collect information about financial strain, employment, family and community support, education, physical activity, substance abuse, mental health, and disabilities. The AHC-HRSN tool is designed to help physicians identify unmet needs and refer affected patients to appropriate community services.

    Patients will be randomized to receive one of three social needs screening instruments. Health Leads is an 8-item survey with yes/no responses, which screens for food insecurity, utility needs, housing instability, childcare, financial resource strain, transportation challenges, education, and social isolation.

    Patients will be randomized to receive one of three social needs screening instruments. The NCCN Distress thermometer is a single-item tool designed to measure patients' current level of distress. Patients are asked to rate their distress using a 10-point Likert scale, where 0=no distress and 10=extreme distress. The Problem List (PL) helps physicians identify the sources of patients' distress and direct patients to appropriate support services. The NCCN DT+PL is a widely used, validated tool for evaluating distress in patients diagnosed with or receiving treatment for cancer.

    Patients who do not respond to the survey within 48 hours of being first administered via MyPennMedicine will be sent the same survey via one of two modality arms. The chatbot is a bidirectional text-based conversational agent administered via WaytoHealth. Patients will again have 48 hours to respond via chatbot.

    Patients who do not respond to the survey within 48 hours of being first administered via MyPennMedicine will be sent the same survey via one of two modality arms. The interactive voice response (IVR) system is administered via phone through WaytoHealth. Patients will be called over the phone and will receive the screening tool through IVR. Patients will again have 48 hours to respond via IVR.

    Outcomes

    Primary Outcome Measures

    Rates of SBDOH screen completion prior to initial surgical consult
    Rates of SBDOH screen completion prior to initial surgical consult will be first compared by instrument (Accountable Health Communities Health-Related Social Needs Screening Tool [AHC-HRSN], Health Leads Social Needs Screening Toolkit [Health Leads], National Comprehensive Cancer Network Distress Thermometer and Problem List [NCCN DT + PL]). Only the NCCN DT employs a 10-point Likert scale, where 0 = no distress and 10 = extreme distress. Among patients who do not respond to initial screening administration and who then receive the screening via either chatbot or IVR, rates of SBDOH screen completion will be compared by modality.

    Secondary Outcome Measures

    Time from biopsy to initial surgical consult
    Time to evaluation (TTE) will be compared first by instrument (Accountable Health Communities Health-Related Social Needs Screening Tool [AHC-HRSN], Health Leads Social Needs Screening Toolkit [Health Leads], National Comprehensive Cancer Network Distress Thermometer and Problem List [NCCN DT + PL]). Only the NCCN DT employs a 10-point Likert scale, where 0 = no distress and 10 = extreme distress. Among patients who do not respond to initial screening administration and who then receive the screening via either chatbot or IVR, rates of SBDOH screen completion will be compared by modality.
    Identify factors associated with rates of post-diagnosis, pre-consultation SBDOH screen completion
    Factors associated with rates of SBDOH screen completion across all instruments (AHC-HRSN, Health Leads, and NCCN DT + PL) and modalities will be assessed via individual semi-structured qualitative interviews with patients who participate in Activity 1 as well as clinicians or clinical leaders.

    Full Information

    First Posted
    August 25, 2023
    Last Updated
    September 5, 2023
    Sponsor
    Abramson Cancer Center at Penn Medicine
    Collaborators
    Gilead Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06019988
    Brief Title
    Effect of Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening and Enhanced Navigation on Care Delivery for Patients With Breast Cancer
    Acronym
    Breast SBDOH
    Official Title
    Effect of Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening and Enhanced Navigation on Care Delivery for Patients With Breast Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 15, 2023 (Anticipated)
    Primary Completion Date
    September 14, 2024 (Anticipated)
    Study Completion Date
    September 14, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Abramson Cancer Center at Penn Medicine
    Collaborators
    Gilead Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The overarching goal of this project is to optimize the collection of social and behavioral determinants of health (SBDOH) for patients with a pathological diagnosis of breast cancer at Penn Medicine. The investigators will measure rates of SBDOH data collection by modality and rates of referral to and uptake of social support services, time to evaluation, staff time, acceptability, patient-centered communication, medical mistrust, and clinician acceptability.
    Detailed Description
    The investigators will conduct a patient-level, pragmatic opt-out trial to test implementation of a comprehensive, tech-enabled platform for administration of a validated SBDOH screening tool in contrast to the current practice of unstructured social history collection at this institution. For internally referred patients, study coordinators - who are functioning as patient navigators - will facilitate a warm handoff from radiology to the New Patient Office as well as study introduction and enrollment. If patients do not wish to have a warm handoff call with a new-patient coordinator (NPC) in the NPO who will schedule the patient's consult with a surgeon and/or oncologist, or if patients are diagnosed external to Penn Medicine, the patient coordinator will follow up directly with the patient to facilitate communication and enrollment within 24 hours of diagnosis. All patients who do not opt out will be part of the analytic cohort and randomized to one of three screening assessment tools: Accountable Health Communities Health-Related Social Needs Screening Tool (AHC-HSRN); Health Leads Social Needs Screening Toolkit (Health Leads); National Comprehensive Cancer Network (NCCN) Distress Thermometer + Problem List (NCCN DT+PL). . The initial request for completion will be administered via the institutional EHR's Epic-based patient portal. Patients will have 48 hours to respond and will receive 2 reminders via a MyPennMedicine message (MPM), through which a patient can also indicate a desire to opt-out if they wish. Patients who do not respond and remain enrolled will be randomized to either a bidirectional text-based conversational agent (i.e., "chatbot") or interactive voice response (IVR) system administered by phone. Through the first arm, patients will engage with the screening tool through an interactive two-way text messaging chatbot through WaytoHealth©. Through the second arm, patients will be called over the phone and will receive the screening tool through interactive voice recognition. Patients will again have 48 hours to respond and will receive 2 reminders via the modality to which they have been newly randomized. Patients have the opportunity to opt out through either modality and discontinue study. Patients who have not completed the screen via any modality by the time of their first surgical consult at Penn after diagnosis, will be provided the opportunity to complete it electronically though a tablet at the clinic appointment. At any point, patients who report challenges with particular SBDOH domains can be referred prior to initial surgical consultation to Social Services at Abramson Cancer Center. Approximately 6 months following diagnosis and initial completion in the study trial (Activity 1), a subset of patients (identified via deviant sampling) will be invited to participate in semi-structured interviews (Activity 2) through which mechanisms contributing to the effectiveness of the SBDOH data collection platform will be evaluated. Additionally, clinicians or clinical leaders will be invited to participate in semi-structured interviews.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    Social and behavioral determinants of health

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    All enrolled patients will initially receive one of three screening tools (The Accountable Health Communities Health-Related Social Needs Screening Tool [AHC-HRSN], Health Leads Social Screening Tool, or National Comprehensive Care Network Distress Thermometer and Problem List [NCCN DT+PL]) via the MyPennMedicine patient portal and be given 48 hours to respond. Those patients who do not respond will be randomized to one of two intervention arms, each of which is an alternative modality to receive and respond to the assigned screening tool: a bidirectional text-based conversational agent (chatbot) or interactive voice response system administered by phone. There exists three instrument arms (AHC-HRSN, Health Leads, and NCCN DT+PL) and two modality arms (chatbot and IVR).
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    2500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    The Accountable Health Communities Health-Related Social Needs Screening Tool (AHC-HRSN)
    Arm Type
    Other
    Arm Description
    Patients will be randomized to receive one of three social needs screening instruments. The AHC-HRSN is a 10-item tool developed by the Centers for Medicare and Medicaid Services to assess patient needs in 5 core domains, including housing instability, food insecurity, transportation problems, utility help needs, and interpersonal safety, with eight supplemental domains to collect information about financial strain, employment, family and community support, education, physical activity, substance abuse, mental health, and disabilities. The AHC-HRSN tool is designed to help physicians identify unmet needs and refer affected patients to appropriate community services.
    Arm Title
    Health Leads Social Screening Tool
    Arm Type
    Other
    Arm Description
    Patients will be randomized to receive one of three social needs screening instruments. Health Leads is an 8-item survey with yes/no responses, which screens for food insecurity, utility needs, housing instability, childcare, financial resource strain, transportation challenges, education, and social isolation.
    Arm Title
    National Comprehensive Care Network (NCCN) Distress Thermometer and Problem List (DT + PL)
    Arm Type
    Other
    Arm Description
    Patients will be randomized to receive one of three social needs screening instruments. The NCCN Distress thermometer is a single-item tool designed to measure patients' current level of distress. Patients are asked to rate their distress using a 10-point Likert scale, where 0=no distress and 10=extreme distress. The Problem List (PL) helps physicians identify the sources of patients' distress and direct patients to appropriate support services. The NCCN DT+PL is a widely used, validated tool for evaluating distress in patients diagnosed with or receiving treatment for cancer.
    Arm Title
    Chatbot
    Arm Type
    Other
    Arm Description
    Patients who do not respond to the survey within 48 hours of being first administered via MyPennMedicine will be sent the same survey via one of two modality arms. The chatbot is a bidirectional text-based conversational agent administered via WaytoHealth. Patients will again have 48 hours to respond via chatbot.
    Arm Title
    Interactive Voice Response (IVR) System
    Arm Type
    Other
    Arm Description
    Patients who do not respond to the survey within 48 hours of being first administered via MyPennMedicine will be sent the same survey via one of two modality arms. The interactive voice response (IVR) system is administered via phone through WaytoHealth. Patients will be called over the phone and will receive the screening tool through IVR. Patients will again have 48 hours to respond via IVR.
    Intervention Type
    Other
    Intervention Name(s)
    Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening
    Intervention Description
    All patients who participate in the trial will receive one of three social and behavioral determinants of health (SBDOH) screening instruments (AHC-HRSN, Health Leads, or NCCN DT + PL). Any patients who do not complete the screening within 48 hours of its administration will be randomized to receive the same screening via one of two modality arms (Chatbot or IVR System)
    Primary Outcome Measure Information:
    Title
    Rates of SBDOH screen completion prior to initial surgical consult
    Description
    Rates of SBDOH screen completion prior to initial surgical consult will be first compared by instrument (Accountable Health Communities Health-Related Social Needs Screening Tool [AHC-HRSN], Health Leads Social Needs Screening Toolkit [Health Leads], National Comprehensive Cancer Network Distress Thermometer and Problem List [NCCN DT + PL]). Only the NCCN DT employs a 10-point Likert scale, where 0 = no distress and 10 = extreme distress. Among patients who do not respond to initial screening administration and who then receive the screening via either chatbot or IVR, rates of SBDOH screen completion will be compared by modality.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Time from biopsy to initial surgical consult
    Description
    Time to evaluation (TTE) will be compared first by instrument (Accountable Health Communities Health-Related Social Needs Screening Tool [AHC-HRSN], Health Leads Social Needs Screening Toolkit [Health Leads], National Comprehensive Cancer Network Distress Thermometer and Problem List [NCCN DT + PL]). Only the NCCN DT employs a 10-point Likert scale, where 0 = no distress and 10 = extreme distress. Among patients who do not respond to initial screening administration and who then receive the screening via either chatbot or IVR, rates of SBDOH screen completion will be compared by modality.
    Time Frame
    1 years
    Title
    Identify factors associated with rates of post-diagnosis, pre-consultation SBDOH screen completion
    Description
    Factors associated with rates of SBDOH screen completion across all instruments (AHC-HRSN, Health Leads, and NCCN DT + PL) and modalities will be assessed via individual semi-structured qualitative interviews with patients who participate in Activity 1 as well as clinicians or clinical leaders.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Based on available EHR data, patients will be eligible for Activities 1 and 2 if they: Are referred to one of the following locations for surgical consult following a new diagnosis of operable (Stage 0-III) breast cancer: the Hospital of the University of Pennsylvania (HUP), Penn Presbyterian Medical Center (PPMC), Pennsylvania Hospital (PAH), and Penn Medicine Radnor Are female Are 18 years of age or older, and Are able to read and speak English or Spanish Clinicians and clinical leaders will be eligible for participation in Activity 2 if they: Presently work as a clinician or clinical leader in breast surgery or oncology Access PennChart as an aspect of their clinical duties Are 18 years of age or older Are able to read and speak English or Spanish Exclusion Criteria: Based on available EHR data, patients will be ineligible if they: Are listed as not wanting to be contacted or solicited for research; Have known metastatic disease at time of enrollment; and/or Do not otherwise meet all of the enrollment criteria Clinicians and clinical leaders will be ineligible for participation in Activity 2 if they: Are not presently engaged in clinical duties or Do not otherwise meet all of the enrollment criteria This study will not exclude men or nonbinary people who may be diagnosed with breast cancer, but investigators anticipate the sample size for these characteristics will be too small to support meaningful analysis.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Julia T Lewandowski
    Phone
    215-662-2861
    Email
    julia.lewandowski@pennmedicine.upenn.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sarah B Hulse
    Phone
    267-408-2477
    Email
    sarah.hulse@pennmedicine.upenn.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Oluwadamilola Fayanju, MD
    Organizational Affiliation
    University of Pennsylvania Division of Breast Surgery
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening and Enhanced Navigation on Care Delivery for Patients With Breast Cancer

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